Radiation Therapy With or Without Chemotherapy in Treating Patients With Advanced Head and Neck Cancer

Phase 3 Completed Cancer Research UK

Treatment

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy plus chemotherapy is more effective than radiation therapy alone in treating patients with advanced head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients with advanced head and neck cancer.

Timeline

Start: 1990-01
Primary completion: —
Completion: 2010-01

Outcome

Mixed primary results

paper The primary endpoints were overall survival (from randomisation), and event-free survival (EFS; recurrence, new tumour, or death; whichever occurred first) PMID 19875337 ↗

paper median overall survival was 2.6 years (99% CI 1.9-4.2) in the radiotherapy alone group, 4.7 (2.6-7.8) years in the SIM alone group PMID 19875337 ↗

paper The corresponding median EFS were 1.0 (0.7-1.4), 2.2 (1.1-6.0), 1.0 (0.6-1.5), and 1.0 (0.6-2.0) years (p=0.005). PMID 19875337 ↗

paper For every 100 patients given SIM alone, there are 11 fewer EFS events (99% CI 1-21), compared with 100 given radiotherapy PMID 19875337 ↗

Publications

Results Tobias JS, Monson K, Gupta N, Macdougall H, Glaholm J, Hutchison I, Kadalayil L, Hackshaw A; UK Head and Neck Cancer Trialists' Group. Chemoradiotherapy for locally advanced head and neck cancer: 10-year follow-up of the UK Head and Neck (UKHAN1) trial. Lancet Oncol. 2010 Jan;11(1):66-74. doi: 10.1016/S1470-2045(09)70306-7. Epub 2009 Oct 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bleomycin	Unknown	—	—
Subject	Leucovorin	Small molecule	—	—
Subject	Methotrexate	Small molecule	—	—
Subject	Vincristine	Small molecule	—	—
Subject	fluorouracil	Small molecule	—	—